Key Responsibilities
* Drive the expansion of the existing manufacturing facility, focusing on filling, inspection, and formulation equipment.
* Develop and implement a comprehensive manufacturing readiness strategy, ensuring seamless startup and validation of new systems and equipment.
* Collaborate with diverse groups to deliver high-quality project outcomes.
* Ensure consistency in equipment design and practices, streamlining processes and tasks for efficiency.
Requirements:
* Bachelor's Degree in Engineering (Mechanical, Electrical, or Chemical) with 4+ years of experience in engineering projects and systems.
* Fundamental knowledge of quality management and regulatory requirements.
* Strong leadership, technical writing, and communication/presentation skills.
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
* Team player promoting clear communication, collaboration, and engagement at all levels for effective decision-making.
* Manufacturing experience in biopharmaceutical formulation/fill/finish facilities.
* Technical ability to resolve complex problems as part of a focused team.
* Vendor management and contract negotiation experience.